Efficacy and Safety of Injectable Semaglutide in Indian Patients with Type 2 Diabetes: Findings from a Phase III Study Presented at IDS 2026

A recent Indian Phase III randomized open-label study has demonstrated that Sun Pharma's injectable semaglutide is non-inferior to international reference innovator semaglutide (Ozempic^®, Novo Nordisk), showing comparable reductions in HbA1c, blood glucose levels, and body weight, along with a similar safety profile in Indian patients with uncontrolled type 2 diabetes mellitus (T2DM).

The study findings were presented at the 10th International Diabetes Summit (IDS) 2026, held from 13–15 March 2026 in Pune, India, as an oral presentation titled “Efficacy and Safety of Semaglutide Injection in Type 2 Diabetes Mellitus: A Phase III Randomized Open-Label Study

Multiple Semaglutide Formulations in India: The Importance of Evidence‑Based Comparability

Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, is an established therapy for the management of type 2 diabetes mellitus due to its effects on glycemic control and body weight reduction. It is available under multiple dosage forms and brand names, including Ozempic^®, Wegovy^®, and Rybelsus^®, and is used as an adjunct to diet and exercise in patients with T2DM. ¹

With several semaglutide formulations now entering the Indian market, clinicians are increasingly faced with questions around therapeutic equivalence, consistency of glycemic outcomes, and safety profiles. In this context, robust head‑to‑head clinical evidence becomes critical when evaluating newer formulations against established reference products.

In this context, an Indian Phase III, randomized, multi-centric, open-label, active-controlled study was conducted to evaluate the efficacy and safety of Sun Pharma’s semaglutide injection in comparison with the international reference innovator (Ozempic^®, Novo Nordisk) in adults with T2DM inadequately controlled on metformin.

Study Overview

A total of 314 patients were randomized (1:1) to receive either the test semaglutide or the reference semaglutide injection. The study included Indian patients with uncontrolled type 2 diabetes mellitus, defined as HbA1c between 7.0% and 10.5%, who were on diet and exercise control, along with a stable dose of metformin of ≥1500 mg or the maximum tolerated dose for a minimum of 12 weeks. The drug was administered subcutaneously once weekly at doses ranging from 0.25 mg to 2 mg over a treatment duration of 24 weeks, followed by a 2-week safety period. A total of 143 patients in the test arm and 147 patients in the comparator arm completed the study.

The primary endpoint of the study was the change in HbA1c at Week 24. Secondary endpoints included changes in fasting blood glucose (FBG), postprandial blood glucose (PPBG), and body weight, along with the proportion of patients achieving HbA1c levels below 7%.

The key findings from the study include:

The study demonstrated comparable efficacy between the test and reference (international innovator) semaglutide arms, confirming non-inferiority. The study showed the following improvements in both the groups at the 24-Week follow-up:

HbA1c reduction: Decreased from 8.62% to 6.58% (−2.04%) in the test arm and from 8.61% to 6.66% (−1.95%) in the comparator arm (international innovator), with no statistically significant difference (p=0.3429), confirming non-inferiority. (Figure 1) The observed ~2% HbA1c reduction in both arms is clinically meaningful and aligns with outcomes seen in global semaglutide trials.

Change from baseline in FBG levels: Decreased from 164.9 to 112.1 mg/dL (−52.8 mg/dL) in the test arm and from 163.5 to 113.2 mg/dL (−50.3 mg/dL) in the comparator arm (international innovator), demonstrating comparable reductions between the groups. (Figure 2)

Change from baseline in PPBG levels: Decreased from 242.7 to 148.4 mg/dL (−94.3 mg/dL) in the test arm and from 240.1 to 155.5 mg/dL (−84.6 mg/dL) in the comparator arm (international innovator), indicating similar improvements in postprandial control. (Figure 2)

Comparable reductions in FBG and PPBG Levels in both arms at all visits.

Body weight reduction: Decreased from 71.7 to 65.5 kg (−6.17 kg) in the test arm and from 73.2 to 67.0 kg (−6.17 kg) in the comparator arm (international innovator), showing comparable weight reduction in both arms. Statistically significant change (p<0.0001) from baseline to each visit within each arm. Mean body weight reduction of approximate 6 kg at 24 weeks in both arms

HbA1c <7% achievement: Achieved in 74.6% of patients in the test arm and 74.0% in the comparator arm (international innovator) at Week 24, reflecting similar target attainment rates.

Figure 1: Change in HbA1c at Week 24 and Change in HbA1c at Week 4, 8, 12, 16 and 20

Figure 2: Change from baseline FBG levels and PPBG levels

Safety outcomes were comparable between the two groups, with adverse events reported in 56.7% of patients in both arms. Most events were mild in nature, with gastrointestinal events such as diarrhea, nausea, and vomiting being the most commonly reported. The low incidence of hypoglycemia is consistent with the glucose-dependent mechanism of action of GLP‑1 receptor agonists, with only 3 events reported overall, all of which were mild. No clinically significant abnormalities or immunogenicity concerns were observed.

Implications for Clinicians: Understand the Evidence-Based Indian Semaglutide

This Indian Phase III study demonstrates that the test semaglutide formulation provides glycemic and metabolic outcomes comparable to the international reference innovator product (Ozempic^®, Novo Nordisk) in patients with uncontrolled type 2 diabetes mellitus. Similar reductions in HbA1c, fasting and postprandial glucose, along with meaningful weight loss, highlight its effectiveness as a once-weekly GLP-1 receptor agonist for comprehensive metabolic control. The safety profile was consistent with known class effects, with predominantly mild gastrointestinal adverse events and a low incidence of hypoglycemia, supporting its tolerability in clinical use. The absence of immunogenicity signals further strengthens its clinical applicability.

In the Indian settings, where achieving glycemic and weight targets remain a challenge among T2D patients, the availability of an innovator comparable semaglutide provides clinicians in India with an additional evidence-based semaglutide option, which may help improve access to effective GLP-1 receptor agonist therapy.